Methods for improving heart valve function

ABSTRACT

A method of deploying a blood-flow controlling device is described for treating a native mitral or tricuspid valve. The blood-flow controlling device includes a blood-flow blocking portion that is slidable over an elongate body portion. The blood-flow blocking portion is preferably an elongate structure fillable with blood having a portion adapted for placement between leaflets of the native valve. An anchor is located on a distal end of the elongate body portion for engagement with heart tissue adjacent a heart apex. An anchor delivery catheter is advanced through the native valve and into an adjacent ventricle. The anchor is then expelled from the anchor delivery catheter into ventricular tissue. The blood-flow blocking portion is then slid along the elongate body portion and positioned between the native leaflets. A locking catheter is then slid along the elongate body portion for locking the blood-flow blocking portion to the elongate body portion.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/823,445, filed Nov. 27, 2017, now U.S. Pat. No. 10,213,305, which isa continuation of U.S. application Ser. No. 14/595,648, filed Jan. 13,2015, now U.S. Pat. No. 9,827,101, which is a continuation of U.S.application Ser. No. 11/750,272, filed May 17, 2007, now U.S. Pat. No.8,932,348, which claims the benefit of U.S. Application No. 60/801,446filed May 18, 2006, and also the benefit of U.S. Application No.60/810,085, filed Jun. 1, 2006, the entire disclosures all of which areincorporated by reference.

BACKGROUND OF THE INVENTION

The present invention relates generally to devices and methods forimproving the function of a defective heart valve. The devices andmethods disclosed herein are particularly well adapted for implantationin a patient's heart for reducing regurgitation through a heart valve.

The function of the heart may be seriously impaired if any of the heartvalves are not functioning properly. The heart valves may lose theirability to close properly due to e.g. dilation of an annulus around thevalve or a leaflet being flaccid causing a prolapsing leaflet. Theleaflets may also have shrunk due to disease, e.g. rheumatic disease,and thereby leave a gap in the valve between the leaflets. The inabilityof the heart valve to close properly can cause a leak backwards (i.e.,from the outflow to the inflow side), commonly referred to asregurgitation, through the valve. Heart valve regurgitation mayseriously impair the function of the heart since more blood will have tobe pumped through the regurgitating valve to maintain adequatecirculation. Heart valve regurgitation decreases the efficiency of theheart, reduces blood circulation, and adds stress to the heart. In earlystages, heart valve regurgitation leaves a person fatigued or short ofbreath. If left unchecked, the problem can lead to congestive heartfailure, arrhythmias or death.

Regurgitation through the mitral valve, sometimes referred to as mitralinsufficiency or incompetence, is a particularly common problem thataffects the health of millions of adults. By some estimates, mitralvalve regurgitation affects as many as one in five people over age 55.The mitral valve is positioned on the left side of the heart between theleft atrium and left ventricle. The mitral valve comprises an annulus,anterior and posterior leaflets, and chordae for attaching the leafletsto papillary muscles. Changes in the geometric configurations of theleft ventricle, papillary muscles and mitral annulus may adverselyaffect the function of the mitral valve and lead to regurgitation. Otherfactors such as disease, calcification, infection and injury may alsocause mitral valve regurgitation.

Heart valve disease, such as mitral valve regurgitation, is typicallytreated by replacing or repairing the diseased valve during open-heartsurgery. However, open-heart surgery is highly invasive and is thereforenot an option for many patients. For high-risk patients, a less-invasivemethod for repair of heart valves is considered generally advantageous.In U.S. Pat. No. 6,210,432 to Solem et al., a less invasive method hasbeen proposed for treating mitral insufficiency without the need forcardiopulmonary by-pass and opening of the chest and heart. The methoduses a device comprising an elongate body having such dimensions as tobe insertable into the coronary sinus, which is a vein thatsubstantially encircles the mitral orifice and annulus and drains bloodfrom the myocardium to the right atrium. The elongate body has twostates, in a first of which the elongate body has a shape that isadaptable to the shape of the coronary sinus, and to the second of whichthe elongate body applies a compressive force along a posterior regionof the mitral valve annulus. The compressive force applied to the mitralvalve annulus pushes the mitral valve leaflets into closer proximity andreduces regurgitation. However, due to variations in the type of mitralvalve disease and the location of the coronary sinus relative to themitral valve annulus, this approach may not be suitable for allpatients.

In another method, catheter-based procedures have been developed fortreating the mitral valve using an “edge-to-edge” approach. In thisapproach, the free edges of the anterior and posterior mitral valveleaflets are attached along a central region to create a mitral valvehaving a double orifice. In one method developed by Edwards LifesciencesCorporation of Irvine, USA, an elongate catheter is advanced into themitral valve for applying suture to the edges of the mitral valveleaflets. A clip is then advanced over the suture to secure the leafletedges together. Although this “edge-to-edge” approach has shown greatpromise, similar to the coronary sinus implant, it has been found thatthis approach may not be suitable for all patients.

U.S. application Ser. No. 11/407,582 to Solem (hereinafter “the '582Application”), entitled “A Blood Flow Controlling Apparatus,” filed onApr. 19, 2006, now Publication No. 2006/0241745, discloses a variety ofdevices and methods for treating heart valves using anotherless-invasive approach. In the '582 Application, the contents of whichare hereby incorporated by reference, preferred embodiments of bloodflow controlling devices are described which are primarily configuredfor delivery into the heart via a percutaneous approach. As described inthe '582 Application, percutaneous methods of treating heart valves areoften desirable, especially for high risk patients, becauseextracorporeal circulation is not required. However, there areconditions in which percutaneous procedures may not be appropriate.Accordingly, there is a need for new procedures for treating heartvalves using minimally-invasive surgical techniques. It is preferablethat such minimally-invasive surgical techniques be capable of treatingheart valves without requiring extracorporeal circulation.

Accordingly, there is an urgent need for an alternative device andmethod of use for treating heart valve disease in a minimally invasiveprocedure that does not require extracorporeal circulation. It isdesirable that embodiments of such a device and method be capable ofreducing or eliminating regurgitation through a heart valve. It is alsodesirable that embodiments of such a device and method be well-suitedfor treating a mitral valve. It is also desirable that such a device besafe, reliable and easy to deliver. It is also desirable thatembodiments of such a device and method be applicable for improvingheart valve function for a wide variety of heart valve defects. It isalso desirable that embodiments of such a device and method be capableof improving valve function without replacing the native valve. Thepresent invention addresses this need.

OBJECTS AND SUMMARY OF THE INVENTION

Various embodiments of the present invention provide improved devicesand methods for improving the function of a defective heart valve.Preferred embodiments are configured to be surgically implanted in aheart using a minimally invasive procedure wherein extracorporealcirculation is not required.

In one preferred embodiment, a blood flow controlling device is providedfor improving valve function. The blood flow controlling devicecomprises a valve-blocking portion (such as an expandable valve portion)and an anchor portion. The valve-blocking portion is configured to bedisposed between anterior and posterior leaflets of a mitral valve. Inan embodiment of a valve-blocking portion, an expandable valve portionexpands during ventricular systole to fill and conform to the gapbetween the mitral valve leaflets, thereby preventing regurgitation. Inone variation, the expandable valve portion comprises a canopy or flapportion and a plurality of tethers. In one preferred embodiment, theblood flow controlling device is configured to be delivered into theheart in a two-stage procedure. More specifically, the anchor portion ofthe device is initially implanted within the heart and the valve portionis then coupled to the anchor portion after the anchor portion hasbecome sufficiently embedded in the muscular wall of the heart.

In another preferred embodiment, a blood flow controlling devicecomprises an anchor portion and an expandable valve portion configuredto be disposed between anterior and posterior leaflets of a mitralvalve. In this embodiment, the expandable valve portion is provided witha plurality of apertures or other openings for allowing some blood toflow backward across the expandable portion. This embodimentadvantageously reduces the formation of thrombi by eliminating thepooling of blood within the expandable member without substantiallyreducing the effectiveness of the device.

Preferred embodiments of the present invention include surgical devicesand methods of treating heart valves wherein a blood flow controllingdevice is delivered into the heart through a small incision in thechest, such as, for example, in the sternum or between the ribs.Preferred embodiments of the surgical methods described herein do notrequire extracorporeal circulation. For example, in one preferredembodiment, a delivery catheter (or similar delivery device) is insertedthrough an incision in the chest wall and then through the cardiactissue into a chamber of the patient's beating heart. The deliverycatheter allows a blood flow controlling device to be delivered into theheart in a collapsed configuration and then expanded within the heartfor treating a defective heart valve. Because the preferred deliverymethods do not require extracorporeal circulation, complications aregreatly reduced as compared with traditional open-heart surgery.

In another preferred embodiment, devices and methods are provided forfacilitating the manufacture of an anchor portion. The devices andmethods are configured for manufacturing an anchor portion having adesired three-dimensional geometry. The devices and methods areparticularly well-suited for creating an anchor portion that conforms tothe shape of a left atrium. In one variation, a disposable jig is usedto mold the anchor portion into a particular three-dimensional shape. Ifdesired, the jig can be created to suit the specific geometry of apatient's left atrium. For example, imaging techniques may be used todetermine the dimensions of the left atrium before creating the jig.After molding the anchor portion, the jig can be removed, such as, forexample, by breaking it into pieces or dissolving, thereby leaving themolded anchor portion. In one preferred variation, the jig is formed ofa gypsum material. If desired, a master jig shape can be used to createadditional disposable jigs having the same shape.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a side view of a device according to the inventiondeployed in a human heart, with the heart depicted in cross-section;

FIG. 2 illustrates a further side view of the heart of FIG. 1, with theheart depicted in a different cross-section and the device deployedtherein;

FIG. 3 depicts a front view of a patient with surgical openings throughwhich the device of the invention may be delivered;

FIG. 4A depicts a front view of a heart, in partial cross section,having a guidewire passing through an entry point in the left atrium andbetween the leaflets of the mitral valve;

FIG. 4B depicts a front view of a heart, in cross section, with adelivery device that has been advanced into the heart over the guidewireof FIG. 4A;

FIG. 4C depicts a front view of a human heart, in cross section, with ananchor portion of a device according to the invention deployed in theheart wall;

FIG. 4D depicts a front view of a human heart, in cross section, with adevice according to the invention partially deployed within the heart;

FIG. 4E depicts a front view of a human heart, in cross section, with adevice according to the invention fully deployed within the heart;

FIG. 5 depicts a front view of a human heat, in cross section, wherein aguidewire is introduced in an alternative delivery method through anentry point in the left ventricle;

FIG. 6 depicts a front view of a heart, in cross section, whereinanother alternative delivery method has a guidewire passing through anentry point in the right ventricle;

FIG. 7 depicts a front view of a heart, in cross section, whereinanother alternative delivery method has a guidewire passing through anentry point in the right atrium;

FIG. 8A depicts a front view of a heart, in cross section, wherein ananchor delivery catheter is advanced to deploy a device of the inventionwithin the heart;

FIG. 8B depicts a front view of the heart of FIG. 8A, in cross section,wherein the anchor delivery catheter is partially withdrawn and ananchor portion according to the invention is deployed within the heartmuscle;

FIG. 8C depicts a front view of the heart of FIG. 8B, in cross section,wherein a second delivery catheter is advanced to deploy a valveblocking portion according to the invention within the heart;

FIG. 8D depicts a front view of the heart of FIG. 8C, in cross section,wherein the device according to the invention is deployed within theheart;

FIGS. 9A and 9B depict side views of an anchor portion according to anembodiment of the invention;

FIGS. 10A-10D illustrate a delivery tool, in partial cross section, fordelivering an anchor portion similar to the one depicted in FIGS. 9A and9B;

FIG. 11 depicts a front view of a heart, in cross section, with ananchor portion, such as the one depicted in FIGS. 9A and 9B, anchoredwithin a left ventricle muscle;

FIG. 12A depicts a perspective view of an anchor portion and elongatebody portion with connectors according to an embodiment of the inventionprior to attachment;

FIG. 12B depicts a perspective view, in cross section, of the anchorportion and elongate body portion with connectors from FIG. 12A in anattached condition;

FIG. 13A depicts a perspective view of an anchor portion and elongatebody portion with connectors according to an embodiment of the inventionprior to attachment;

FIG. 13B depicts a perspective view, in cross section, of the anchorportion and elongate body portion with connectors from FIG. 13A in anattached condition;

FIG. 14 depicts a front view of a heart, in cross section, with a deviceaccording to an embodiment of the invention;

FIGS. 15 and 16 depict side views (with 16 being a close-up view) of adevice according to an embodiment of the invention;

FIG. 17 depicts a front view of a heart, in cross section, with a deviceaccording to a further embodiment of the invention;

FIG. 18 depicts a front view of a heart, in cross section, with a deviceaccording to a further embodiment of the invention;

FIGS. 19A and 19B are perspective views of a master jig used in themanufacture of anchor portions configured for deployment in a leftatrium according to an embodiment of the invention;

FIG. 20 is a perspective view of a silicone mold formed using a masterjig according to an embodiment of the invention;

FIG. 21 is a perspective view of a disposable jig formed using thesilicone model of FIG. 20; and

FIG. 22 is a perspective view of an anchor device formed from thedisposable jig of FIG. 21.

DETAILED DESCRIPTION OF THE INVENTION

With reference to FIG. 1, a device 10 according to the invention isdepicted in a heart 12. The heart 12 has four chambers, known as theright atrium 14, right ventricle 16, left atrium 18, and left ventricle20. In the particular embodiment depicted, the device 10 is deployed inthe left ventricle 20.

The general anatomy of the heart 12, which is depicted as viewed fromthe front of a patient, will be described for background purposes. Theheart 12 has a muscular outer wall 22, with an interatrial septum 24(not visible in FIG. 1, but visible in FIG. 3b , etc.) dividing theright atrium 14 and left atrium 18, and a muscular interventricularseptum 26 dividing the right ventricle 16 and left ventricle 20. At thebottom end of the heart 12 is the apex 28.

Blood flows through the superior vena cava 30 and the inferior vena cava32 into the right atrium 14 of the heart 12. The tricuspid valve 34,which has three leaflets 36, controls blood flow between the rightatrium 14 and the right ventricle 16. The tricuspid valve 34 is closedwhen blood is pumped out from the right ventricle 16 through thepulmonary valve 38 to the pulmonary artery 40 which branches intoarteries leading to the lungs (not shown). Thereafter, the tricuspidvalve 34 is opened to refill the right ventricle 16 with blood from theright atrium 14. Lower portions and free edges 42 of leaflets 36 of thetricuspid valve 34 are connected via tricuspid chordae tendinae 44 topapillary muscles 46 in the right ventricle 16 for controlling themovements of the tricuspid valve 34.

After exiting the lungs, the newly-oxygenated blood flows through thepulmonary veins 48 and enters the left atrium 18 of the heart 12. Themitral valve 50 controls blood flow between the left atrium 18 and theleft ventricle 20. The mitral valve 50 is closed during ventricularsystole when blood is ejected from the left ventricle 20 into the aorta52. Thereafter, the mitral valve 50 is opened to refill the leftventricle 20 with blood from the left atrium 18. The mitral valve 50 hastwo leaflets (anterior leaflet 54 a and posterior leaflet 54 p), lowerportions and free edges 56 of which are connected via mitral chordaetendinae 58 to papillary muscles 60 in the left ventricle 20 forcontrolling the movements of the mitral valve 50. Blood from the leftventricle 20 is pumped by power created from the musculature of theheart wall 22 and the muscular interventricular septum 26 through theaortic valve 62 into the aorta 52 which branches into arteries leadingto all parts of the body.

With reference now to FIG. 2, one preferred embodiment of a blood flowcontrolling device 10 is described and depicted in more detail, with thecutaway view of the heart 12 taken from a position slightly deeperwithin the heart 12 than in FIG. 1 and thus behind anterior heartstructures which had been depicted in FIG. 1 (such as the anteriormitral valve leaflet 54 a, etc.) to provide a better view of the device10. The device 10 can include an anchor portion 70 having one or moreanchor members 72, such as screw blades or a plurality of hooks, thatembed themselves into the muscular wall 22 of the heart 12. An elongatedbody portion 74 extends from the anchor portion 70, connecting theanchor portion 70 to the canopy 76 and tethers 78. The elongated bodyportion 74 can be generally flexible, generally rigid, bendable, formedfrom a memory material, etc. In the particular embodiment depicted, theelongated body portion 74 is positioned through tile mitral valve 50,and provides a framework for the canopy 76 and the tethers 78.Additional details regarding the construction of a blood flowcontrolling device 10 for use with the invention can be found in the'582 Application, the contents of which have been specificallyincorporated by reference. The canopy 76 of the device 10 thus acts toblock the leaking or regurgitating central opening of the mitral valve50 during ventricular systole. The canopy 76 will generally duringinflow through the mitral valve 50, but then inflating in a generallyparachute-like fashion during ventricular systole to assist in closingthe mitral valve 50.

With reference to FIG. 3, one preferred method of accessing the heart 12of a patient 80 for minimally-invasive surgery is illustrated. Moreparticularly, access to the heart 12 is achieved by creating one or moreincisions 82 a, 82 b in the chest wall 84 Incisions can be createdbetween the patient's ribs (as in incisions 82 a) or by splitting thepatient's sternum (as in incision 82 b). In either approach, externalsurfaces of one or more chambers of the patient's heart may beaccessible.

Next, the user selects a desired entry point in the heart through whichthe delivery catheter is to be inserted. The location of the entry pointinto the heart will typically depend on the type of blood flowcontrolling device used (e.g., the devices disclosed the '582Application) and also on which heart valve (e.g., mitral valve) istargeted for treatment. Examples of various entry points into the heartare described in greater detail below.

With reference to FIG. 4A, in one preferred delivery method, a guidewire90 is introduced through an incision 92 in the left atrium 18 and isadvanced between the anterior and posterior leaflets 54 a, 54 p of themitral valve 50. Since the heart 12 continues to beat during thisprocedure, steps are preferably taken to minimize blood loss through theincision 92. For example, a purse-string suture 94 can be used in anarea 96 around the incision 92 to maintain closure of the incision 92around the guidewire 90 and thereby minimize blood loss.

With reference to FIG. 4B, an elongate delivery catheter 98 is advancedover the guidewire 90 to a desired delivery location 100 within theheart 12. The delivery catheter 98 has the blood flow controlling device10 secured therewithin. A distal end 102 of the delivery catheter 98 hasthe anchor 70 secured therewithin, and is positioned within the leftventricle 20. The position of the delivery catheter 98 allows deploymentof the anchor 70 into a desired portion of the heart wall 22 in the leftventricle, supporting deployment of the blood flow controlling device 10for treating valve regurgitation. To ensure that the delivery catheter98 and blood flow controlling device 10 are properly positioned withinthe heart 12, contrast dye can be injected in the area, which may beaccomplished by injecting the contrast dye through the delivery catheter98. Alternatively or in addition, other imaging techniques, such as, forexample, ultrasound, may be used to determine the position andorientation of the delivery catheter 98 and/or blood flow controllingdevice 10 within the heart 12. In other alternative procedures, adelivery catheter may be advanced into the heart without the use of aguidewire.

In FIG. 4C, the anchor 70 of the device 10 has been extended out of thedelivery catheter distal end 102 (which may include retracting thedelivery catheter 98 from around the device 10 and/or pushing the device10 out of the delivery catheter 98). The anchor portion 70 may includeanchor members 72 in the form of arms or hooks that expand outward asthe anchor portion 70 is exposed, and which are configured to engage andembed into the muscular heart wall and/or other heart tissue, such asthe heart wall 22 at or adjacent the heart apex 28. Note that becausethe heart wall 22 at the apex 28 itself is often relatively thin, but isoften thicker in the areas spaced slightly away from the apex 28, it maybe desirable to deploy the anchor portion 70 into the heart wall 22 inan area adjacent but slightly spaced away from the apex 28 in order totake advantage of the thicker tissue in which to deploy the anchorportion 70.

After the anchor portion 70 is securely deployed in the heart tissue,the delivery catheter 98 can be further retracted, as depicted in FIG.4D, exposing additional portions of the device 10, including theelongate body portion 74, the connecting tethers 78, and part of thecanopy 76. In FIG. 4E, the delivery catheter 98 is completely removedfrom the device 10. The device 10 is thus deployed, with the canopy 76expanding against the mitral valve leaflets 54 a, 54 p or otherwiseblocking at least a portion of the mitral valve opening to reduce orprevent backflow of blood through the mitral valve 50. Accordingly, thedevice 10 is configured to improve the function of the mitral valve 50by reducing or eliminating regurgitation through the mitral valve 50without impeding the flow of blood through the heart 12. After thedevice 10 is positioned and deployed in the desired position within theheart 12, the delivery catheter 98 is withdrawn from the body and thepurse string suture 94 is tied such that no bleeding occurs through theincision 92.

Note that the deployment depicted in FIGS. 4A-4E was conducted throughthe heart wall around the left atrium 18, and involved deploying thedevice 10 using a single delivery catheter 88 with the device 10 beingdeployed in one piece. Depending on the particular application, however,other approaches may be used to enter the heart 12, and the device 10may be deployed as one or more separate pieces (e.g., anchor portion,elongate body portion, tethers, and canopy), with different pieces beingdeployed independently and in separate stages and then connectedtogether during the deployment process. Some examples of differentapproaches into the heart are described below and depicted in FIGS. 5,6, and 7, while an embodiment of an independent deployment procedure isdescribed below and depicted in FIGS. 8A-8D.

It will be appreciated that embodiments of the present invention may beapplicable to delivery methods utilizing alternative entry points intothe heart 12 With reference to FIG. 5, another preferred entry point isillustrated wherein an incision 92 is created at the base of the heart12 at or adjacent the apex 28 of the heart 12, and more specifically theapex of the left ventricle 20. As described above, if necessary, a pursestring suture 94 may be used to control bleeding and a guidewire 90 maybe inserted through the incision 92 and between the mitral valveleaflets 54 a (not shown) and 54 p for facilitating advancement of adelivery catheter into the heart. A delivery catheter can be advancedthrough the incision 92 along and/or over the guidewire 90 and betweenthe mitral valve leaflets 54 a (not shown) and 54 p. By selecting a leftventricle entry point, the user may, for example, more easily deliver ablood flow controlling device that has an anchor portion configured forengagement in the left atrium 18.

With reference now to FIG. 6, another entry point is illustrated whereinaccess into the heart 12 is provided via an incision 92 into the rightventricle 16, with a guide wire 90 advanced between the leaflets 34 ofthe tricuspid valve 34. This entry point may be used for delivering ablood flow controlling device into the right side of the heart 12 forimproving the function of a tricuspid valve 34. Similarly, withreference to FIG. 7, another entry point is illustrated wherein accessto the heart 12 is provided via an incision 92 into the right atrium 14.Selection of the entry point will depend on numerous factors, such as,for example, the configuration of the anchor portion (e.g., ventricularor atrial engagement) and the type of valve (e.g., mitral or tricuspid)being treated.

As discussed above, the device 10 may be deployed as a single piece, ormay be deployed in two or more separate pieces which are assembledduring a multi-stage deployment. While the previously described deliverymethods have been generally directed toward a single stage deliveryprocedure, it should be understood that embodiments of the presentinvention are well suited for delivery in multiple stages. For example,a delivery procedure may include a first stage in which only an anchorportion of a blood flow controlling device is delivered. A second stagemay be performed just after the first stage, or at a later time (e.g.,day or weeks later) wherein the valve portion of the device is connectedto the anchor portion. The time between the first and second stages maybe sufficient to advantageously allow the heart tissue to heal and evengrow over the anchor portion, thereby further embedding the anchorportion in the heart. Without the added stress that the valve portion ofthe device may impart on the tissue, the healing around and over-growthover the anchor may proceed more rapidly with less adverse affects(e.g., unwanted scarring).

FIGS. 8A through 8E depict a two-stage deployment procedure, wherein ananchor portion 70 is deployed in the first stage, and then the remainingstructure of the device 10 is advanced to the site and connected to theanchor portion 70 in situ.

In FIG. 8A, an anchor deployment catheter 110 is shown having a distalend 112 advanced to a desired deployment site within the left ventricle20. The anchor portion 70 is positioned at the anchor deploymentcatheter distal end 112, and more specifically is contained within theanchor deployment catheter distal end 112. The anchor portion 70includes multiple anchor members 72 configured to expand outward andembed within the heart tissue when released from the anchor deploymentcatheter 110, which can be accomplished by pushing the anchor portion 70out of the anchor deployment catheter 110 and/or withdrawing the anchordeployment catheter 110 from around the anchor portion 70.

In FIG. 8B, the anchor portion 70 has been deployed, with the anchormembers 72 embedded into the heart tissue in the lower portion of theleft ventricle 20 adjacent the apex 28. The anchor portion 70 has a topportion 112 having an anchor connector 114 configured to receive amating connector from the rest of the device (i.e., elongate member,canopy, etc.) which will be deployed in the second stage (discussedbelow). The anchor portion 70 also includes an anchor line opening 116,which is a loop or lumen through which an anchor line 118 can be passed.The particular anchor line 118 depicted in FIG. 8B is a line of suturethat passes into the patient and into the heart 12, passes through theanchor line opening 116, and then passes back out of the heart 12 andthe patient to form a double suture line. As the anchor deploymentcatheter 110 is removed from the heart 12, the anchor line 118 is lefttrailing out of the heart 12 and patient.

FIG. 8C depicts the second stage of the deployment procedure, whereinthe rest of the device is advanced into the heart 12 and secured to theanchor portion 70. A second deployment catheter 120, to which is secureda valve portion 130 (i.e., the combination of the elongate body portion74, tethers 78, and canopy 76), is advanced to the area in the leftventricle at or adjacent the previously-deployed anchor portion 70. Inthe particular embodiment depicted, the second deployment catheter 120is an over-the-wire type catheter having an inner lumen configured topermit the anchor line 118 to slidingly pass therethrough. Note,however, that a so-called rapid-exchange type of delivery catheter couldalso be used. The second deployment catheter 120 includes a canopycontainer in the form of a side pocket 124 configured to contain andrestrain the canopy 76 during delivery.

As depicted in FIG. 8C, the second deployment catheter 120 is advancedalong the anchor line 118 to the anchor portion 70. The elongate bodyportion 74 includes a distal end 126 having a connector 128 configuredto be secured to the anchor portion connector 114. As the seconddeployment catheter 120 is advanced along the anchor line 118, theelongate body portion distal end 126 and connector 128 will be led intoalignment and contact with the anchor portion connector 114. When theelongate body portion connector 128 contacts the anchor portionconnector 114, the two connectors 114, 128 are connected together. Notethat many different types of connectors are within the scope of theinvention, and the particular connectors used with a particular devicemay be a matter of choice. The connectors may be snap-type orquick-connect connections which automatically connect when the twoconnectors are brought into contact. The connectors may be manuallyoperated, and/or may include a release device to permit disconnection ata later time.

Connection of the two connectors 114, 128 effectively secures the anchorportion 70 to the elongate body portion 74, and thus to the tethers 78and canopy 76. Once the two connectors 114, 128 are connected, thesecond deployment catheter 120 can be withdrawn, which will release thecanopy 76 from the side pocket to deploy the elongate body member 74,tethers 78, and canopy 76, as depicted in FIG. 8D. In the particularmethod depicted, the anchor line 118 is still depicted in positionpassing through the anchor line loop 116 (although the anchor line 118could have been removed along with, or even prior to, removal of thesecond deployment catheter 120). The anchor line 118 can now be removed,which in the case of the double suture line depicted can involvereleasing one end of the line that passes outside of the heart, andpulling on the other end passing outside the heart. The loose end of thedouble suture line will thus be pulled into the heart 12 and will bepulled out of the anchor line loop 116, thus releasing the anchor line118 from the anchor portion 70. With the second deployment catheter 120and anchor line 118 removed from the patient, the device 10 is fullyassembled and deployed.

Note that a two-stage deployment device and method such as that depictedin FIGS. 8A-8D could be useful for situations where a user desires toreplace a canopy or other portion of a device. For example, if after thedevice is entirely deployed in a patient's heart, a user may determinethat the expandable valve portion is not of the optimal size or not atan optimal distance from the anchor. Such situations may arise where oneor more portions of the patient's heart (e.g., the valve, etc.) hasdeformed since the initial deployment procedure. In such a situation, auser could remove the initially-deployed expandable valve portion whileleaving the anchor portion in place. The user could then attach anotherexpandable valve portion to the anchor portion. Alternatively, the usercould simply leave the initial anchor portion in place without attachinganother expandable valve portion thereto. The user could also deploy asecond expandable valve portion using a second anchor portion.

With reference to FIGS. 9A and 9B, for purposes of illustration, anotherembodiment of an anchor portion 132 is described in more detail. Theillustrated anchor portion 132 is particularly well suited for use witha multistage implantation procedure wherein the anchor portion 132 isdelivered before a valve portion. The anchor portion 132 comprises atubular body 133 having a distal end 134 and a proximal end 136, with aplurality of elongated prongs 134 located on the distal end 134 and acoupling member 140 located on the proximal end 136. In the illustratedembodiment, the coupling member 140 takes the form of a loop.

The elongated prongs 138 may be configured to self-expand from thecompressed configuration of FIG. 9A to a “flowered” or expandedconfiguration of FIG. 9B. This expansion may be achieved with aself-curving area 142 that deflects the elongated prongs 138 radiallyoutward from the center of the generally tubular body 133. The prongs138 may be pointed and/or barbed to facilitate penetration of andengagement with the muscular wall of the heart.

The anchor portion 132 may be formed from various materials and/orcombinations thereof. In one embodiment, the anchor portion 132 isformed from a single tube of shape memory material, such as, forexample, Nitinol. During manufacture, the shape memory material (orother material forming the anchor portion 132) may be cut using amechanical or laser cutting tool. After cutting the tube, the expandedor flowered shape can be imparted to the memory of the shape memorymaterial with techniques known in the art (e.g. heat setting the shape).

The surface of the anchor portion 132, including the prongs 138, may beconfigured to promote tissue growth onto and even into its surface. Inone example this growth is achieved by providing a relatively roughand/or porous surface along the anchor portion 132. Additionally,biological coatings of the types known in the art can be included on thesurface of the anchor portion 132 to promote healing and tissue growth.

With reference to FIGS. 10A through 10D, a method of deploying theanchor portion 132 will be described in more detail. As shown in FIG.10A, an anchor portion 132 is secured within a distal end portion 145 ofan anchor delivery catheter 144. The distal end portion 145 includes adistal end sheath 146 that surrounds the anchor portion 132 andmaintains the anchor portion 132 in a compressed configuration duringdelivery to a treatment site. The anchor delivery catheter 144 alsoincludes an expandable structure such as an expandable balloon 148,which in the embodiment depicted is positioned around a portion of thedistal end sheath 146.

Using the illustrated delivery system, the anchor delivery catheterdistal end portion 145 containing the anchor portion 132 is advancedthrough a chest wall and through the cardiac tissue (or through otherdelivery routes) into a desired heart chamber. When the anchor portion132 and surrounding distal end sheath 146 are advanced just past theorifice of the valve to be treated (such as a mitral valve as depictedin FIGS. 8A-8D or a tricuspid valve), the expandable balloon 148 can beexpanded, as depicted in FIG. 10B. The expandable balloon 148 whenexpanded can assist in advancement of the anchor delivery catheterdistal end portion 145 past the chordae tendinae and other sub-valvularstructures by preventing the anchor delivery catheter distal end portion145 from becoming entangled within or otherwise passing between suchstructures in an undesired manner.

When the anchor delivery catheter distal end portion 145 is advancedsuch that the anchor portion 132 is properly positioned at a desiredtarget location within the heart, the distal end sheath 146 is retractedproximally with respect to the anchor portion 132, as illustrated inFIGS. 10C and 10D. As the anchor portion 132 is exposed, the prongs 138expand outwardly. In some embodiments, the expansion of the prongs 138may advantageously pull the anchor portion 132 out of the anchordelivery catheter 144 and outer sheath 148.

After being released from the outer sheath 148, the prongs 138 on theanchor portion 132 may continue to expand, bending back around towardsthe generally tubular body 133 while grabbing nearby heart tissue. Thistissue-engaging action by the prongs 138 can help to maintain the anchorportion 132 in a stable position within the heart that resists movementdue to heart beats, blood flow, and similar actions. In this respect,the anchor portion 132 may at least partially “self-deploy” within theheart, requiring little or no extra pressure from the anchor deliverycatheter 144 to anchor within the muscular wall of the heart. Note thatalthough FIGS. 10C and 10D depict the expandable balloon 148 in adeflated condition, the expandable balloon 148 can be left inflatedduring deployment of the anchor portion 132.

In the embodiments of FIGS. 10A-10D, the anchor line 118 took the formof a wire 147 secured to the anchor portion 132 via an anchor portionconnection in the form of a screw-like connection 149, details of whichare depicted in greater detail in FIG. 12B. The wire 147 can berelatively thick and configured to transmit axially rotational movementalong its length. When the user desires to remove the wire 147, the usercan rotate a proximal portion of the wire 147 (which may be positionedoutside of the patient's body), thereby causing a corresponding rotationof the distal portion of the wire 147 and the screw-like connection 149to the anchor portion 132. This rotation will essentially unscrew thescrew-like connection 149, thereby disconnecting the wire 147 from theanchor portion 132. The wire 147 can also serve to retract the anchorportion 132 back into the distal end sheath 146 during or afterdeployment thereof. For example, in the event that the user is notsatisfied with the initial deployment of the anchor portion 132, theuser can pull on the wire 147 while holding still or even advancing thedistal end sheath 146. As the anchor portion 132 is drawn back into thedistal end sheath 146, inward pressure on the prongs 138 from the distalend sheath 146 will cause the prongs 138 of the anchor portion 132 tocollapse inwardly, thereby collapsing the anchor portion 132 back to itsdelivery (i.e., predeployment) condition as the anchor portion 132 ispulled back into the distal end sheath 146. The user can then redeploythe anchor portion 132 in a new position, or can remove the anchorportion 132 entirely from the patient.

With reference now to FIG. 11, the anchor portion 132 is shown some timeafter anchor deployment into the muscular wall of the left ventricle 20(i.e., after the first stage of the implantation procedure). Afterimplantation in the heart 12, endocardial tissue 150 has grown over theexposed tubular portion 133 of the anchor portion 132 that is protrudingfrom the muscular wall 22 into the left ventricle 20, preferably leavingonly the anchor coupling member 140 exposed within the left ventricle20. Simultaneously, inside the heart wall 22 around the embeddedportions of the anchor portion 132 a scarring healing takes place,wherein fibrocytes create strong scarring tissue surrounding the prongs138, thereby integrating them with the muscle of the heart wall 22 tocreate a very strong attachment. It has been found that adequate tissueovergrowth on the exposed areas of the anchor portion 132 and the scarhealing around the prongs 138 may occur in two or three weeks. However,the amount of time required may depend on various factors, such as thelocation of the anchor portion 132 within the heart 12, the surfacefeatures or coatings of the anchor portion 132, and finally the healthstatus and other characteristics of the patient.

The coupling member 140 provides a point of attachment for connecting avalve portion (such as the elongate body portion 74, tethers 78, andcanopies 76 of previously described preferred embodiments) during asecond or later implantation stage. During the second stage, the valveportion may be delivered into the heart using a procedure similar tothat described above with respect to FIGS. 8A-8E.

Note that FIG. 11 does not depict an anchor line (such as the anchorline 118 in the form of the wire 147 from FIGS. 10A-10D) as beingpresent, although depending on the particular embodiment and applicationone or more anchor lines may be left attached to the anchor after anchordeployment for subsequent use in guiding the expandable valve portion tothe anchor during attachment of the expandable valve portion to theanchor. While a user may be able to couple the valve portion to theanchor portion by simply searching around the patient's heart,additional techniques can be used to facilitate this procedure. Forexample, anchor lines such as those depicted and described with respectto FIGS. 8A-8E and FIGS. 10A-10D could be used, such as where an anchorline is left secured to the coupling member during the firstimplantation stage and left within the patient for use during the secondstage. During the second implantation stage, the attachment mechanism ofthe valve portion can attach to the thread, which guides the attachmentmechanism directly to the coupling member located on the anchor portionwithin the heart. As another example, both the coupling member on theanchor portion and the corresponding attachment mechanism of the valveportion may be magnetized, thereby allowing the two to be drawn togetherwhen in close proximity. In yet another example, navigation can befacilitated with cameras, X-rays, or similar techniques which allow theuser to visualize the coupling member within the patient. In stillanother example, a vacuum assisted connection is used to facilitateconnection of the valve portion to the coupling member.

FIGS. 12A-12B depict a further embodiment of connection mechanismsapplicable to an anchor 132 and elongate body portion 152. In theparticular embodiment depicted, the anchor proximal end 136 includes acoupling member 140 in the form of a generally tubular projection 154having outwardly extending locking clips 156 that can be bent inwardlyin response to inward pressure but will snap back outward once theinward pressure is released. The elongate body portion 152 has a distalend 158 including an attachment mechanism 160 with a ring-like structure162 configured to be advanced along the anchor line 118 and to passgenerally tightly around the anchor generally tubular projection 154.

The anchor portion 132 includes an anchor line connection in the form ofan inner lumen 151 configured to receive and interactively couple withthe screw-like anchor connection 149 of the wire 147 of the anchor line118. The interaction between the anchor portion inner lumen 151 andscrew-like anchor connection 149 thus secures the anchor line 118 to theanchor portion 132.

The ring-like structure 162 can be advanced to the anchor portion 132along the anchor line 118, with the wire 147 of the anchor line 118serving as a guide to lead the ring-like structure 162 to the generallytubular projection 154 of the anchor portion 132. As the ring-likestructure 162 passes over the generally tubular projection 154 of theanchor portion 132, the locking clips 156 are forced inward by pressurefrom the ring-like structure 162, but then spring back outwardly to lockonto an inner ridge 164 inside the ring-like structure 162, therebylocking the elongate body portion 152 to the anchor portion 132 asdepicted in FIG. 12B.

After the elongate body portion 152 is secured to the anchor portion132, the anchor line 118 can be disconnected from the anchor portion 132by rotating the wire 147 to “unscrew” the screw-like anchor connection149 of the wire 147 from the anchor portion inner lumen 151. With theanchor line 118 disconnected from the anchor 132, the anchor line 118can be removed from the patient.

FIGS. 13A-13B depict a further embodiment of connection mechanismsapplicable to an anchor 132 and elongate body portion 152. In theparticular embodiment depicted, the anchor proximal end 136 includes acoupling member 140 in the form of a plurality of locking extensions 166having inwardly-directed projections 168, with the locking extensions166 forming a generally tubular (albeit radially incomplete) structuredefining an anchor lock opening 170 therein. The locking extensions 166can be bent outwardly in response to outward pressure, but will snapback inward once the outward pressure is released. The elongate bodyportion 152 has a distal end 158 including an attachment mechanism 160with a generally tubular structure 172 configured to pass generallytightly into the anchor lock opening 170. The generally tubularstructure 172 includes a generally conical surface 174 angled to gentlyease the anchor locking extensions 166 outwardly as the generallytubular structure is advanced into the anchor lock opening 170. Thegenerally conical surface 174 ends in a disk-like surface 176 configuredto interact with the inwardly-directed projections 168 of the anchorlocking extensions 166 to prevent the attachment mechanism 160 frombeing removed from the coupling member 140, as depicted in FIG. 13B.

With reference now to FIG. 14, an alternative blood flow controllingdevice 180 includes an anchor portion 182 configured for penetrating theheart wall 22 within the left ventricle 20. In the illustratedembodiment, the anchor portion 182 includes an inner anchor plate 182 band an outer anchor plate 182 b. In preferred embodiments, the inner andouter plates 182 a, 182 b may be made of a shape-memory material, suchas, for example, Nitinol. As a result, the plates 182 a, 182 b may beconstrained in a collapsed configuration during delivery and thenself-expand when ejected from a delivery catheter. In the expandedconfiguration, the plates 182 a and 182 b prevent the generally elongatebody 184 of the device 180 from moving relative to the heart wall 22.Over time, the anchor portion 182 becomes overgrown with tissue whichfurther secures the device 180 within the heart 12. The canopy 186 orother blocking structure secured to the elongate body portion 184 servesto at least partially block the mitral valve opening to prevent mitralvalve regurgitation.

Although a variety of anchor embodiments have been described forpurposes of illustration, it will be appreciated that a wide variety ofanchor devices may be utilized while remaining within the scope of theinvention. For example, anchor members such as hooks, arms, sutures orother suitable structures may be used. In other configurations, anchorportions used with the blood flow controlling device may be shaped forattachment to different locations in the heart. Although certaindelivery methods have been described above with respect to anchorportions shaped for attachment to the ventricular wall, anchor portionsmay be shaped for deployment within a left or right atrium.

With further reference to FIG. 14, the device 180 includes apertures 190in the canopy 186 that may reduce the formation of clots, thrombosis,embolism, and similar complications that might be caused by stagnantblood that might become trapped within the curvature of the canopy 186.The apertures 190 allow a small amount of blood to pass through thecanopy 186 when the valve 50 and the device 180 are in a closedposition, allowing movement and circulation of the blood near the canopy186.

In the embodiment depicted in FIG. 14, two apertures 190 are shown inthe canopy 186; however, other numbers and arrangements of the apertures190 are also within the scope of the invention. For example, a singleaperture may be located near the center of a canopy or other blood-flowblocking structure. In another example, a plurality of small aperturescan be distributed across a canopy or other blood-flow blockingstructure.

In many of the above figures, the blood flow controlling device includesa generally parachute-like structure that acts to at least partiallyblock the valve opening. However, other structures for at leastpartially blocking the valve opening are also within the scope of theinvention, including hinged structures, solid structures, etc.

The desired distance from an anchor portion to the canopy or otherblood-flow blocking device depends on various factors, such as thedesired anchor deployment location, the size of the heart, the conditionof the heart valve, etc. The specific distance for a particular patientor procedure may not be evident until the procedure is actuallyunderway. It may thus be desirable to have a device in which thedistance between the anchor and blood-flow blocking device can be easilyadjusted by the surgeon or other user.

FIGS. 15 and 16 depict a device 200 that includes an anchor portion 202,an elongate body portion 204, and a blood-flow blocking portion 206. Theblood-flow blocking portion 206 is positioned on the elongate bodyportion 204, with the elongate body portion 204 slidingly passing insideof the blood-flow blocking portion 204 and exiting from its top 208through a bendable lumen 210. The bendable lumen 210 is plasticallydeformable. The user can slide the blood-flow blocking portion 204 upand down with respect to the anchor portion 202. When the distance 212between the blood-flow blocking portion 206 and the anchor portion 202is determined to be optimal (which the surgeon or other user candetermine in a beating heart by observing the heart function via variousprocedures and methods, including fluoroscopy, echo, etc.), the user canlock the blood-flow blocking portion onto the elongate body portion 204by deforming the bendable lumen 210 to a shape that will no longerpermit the elongate body portion 204 to slide therethrough, as depictedin FIG. 16. In the particular embodiment depicted, the deformation ofthe bendable lumen 210 is achieved by a locking catheter 214 which isslidingly advanced along the elongate body portion 204 and over thebendable lumen 210. When an inner structure 216 of the locking catheter214 is engaged against an at least partially rotatable wedge-likestructure 218, the wedge-like structure 218 pulls on a knob 220 whichpulls the bendable lumen 210 into the locking catheter 214 and causesthe bendable lumen 210 to deform to a bent shape that no longer permitsthe elongate body portion from sliding therethrough.

FIG. 17 depicts a further embodiment of the invention, wherein a device230 includes an anchor portion 232, a blood-flow blocking portion 234,and a spacer portion 236 in the form of an elongate body configured topermit the blood-flow blocking portion 234 to be positioned at adistance from the anchor portion 232 for placement at or adjacent avalve, which in the particular embodiment is a mitral valve 50. Thedevice 230 further includes a leash 238 which is secured at one end tothe blood-flow blocking portion 234 and at the other end to tissue 240of the heart wall 22 within the left atrium 18. The leash 238 generallyrestrains unwanted movement of the blood-flow blocking portion 234. Forexample, the leash 238 may prevent the blood-flow blocking portion 234from moving out of the desired location at or adjacent the opening inthe valve 50. The leash 238 may be relatively loose, so that it onlyrestrains movement of the blood-flow blocking portion 234 it theblood-flow blocking portion 234 moves significantly from the desiredlocation, such as may be the case in the event of a catastrophic failureof the anchor 232 or spacer portion 236. The leash 238 may also beuseful for embodiments wherein the spacer portion 236 is generallyflexible, such as where the spacer portion 236 is suture, in which casethe least 238 will serve to prevent the blood-flow blocking portion 234from moving toward the anchor portion 232.

With some blood flow controlling devices, it may be desirable toconstruct anchor portions having relatively complicated geometries tobetter maintain the position of the device within the heart. Forexample, geometries of anchor portions that more precisely conform tothe contours of a heart chamber may be more likely to remain in adesired position and orientation within the heart. Examples of suchdevices are disclosed in pending U.S. Utility patent application Ser.No. 11/227,642, entitled “Device and Method for Treatment of Heart ValveRegurgitation,” which was filed on Sep. 24, 2005, now Pub. No.2006/0058871, the entire contents of which are expressly incorporatedherein by reference. FIG. 18 depicts a device 240 including a blood-flowblocking portion (i.e., valve portion) 242 and an anchor portion 244. Arelatively short space portion 246 may also be included. The particularanchor portion 244 is a generally cage-like structure 248 formedgenerally in the shape of the left atrium 18 and configured fordeployment therewithin. A plurality of wire-like elements 250 forms thecage-like structure 248. The wire-like elements 250 may be formed from ashape-memory material, such as Nitinol, with the general shape of theright atrium “programmed” into the shape-memory material of cage-likestructure during its construction using known techniques, such as heattreatment. The anchor portion 244 can thus be compressed for deliveryinto the right atrium 18, and then expanded in situ wherein the bodytemperature of the patient will cause the cage-like structure 248 toassume its programmed shape to correspond to the shape of the rightatrium 18.

Complex shapes such as shapes corresponding to a particular heartchamber of a particular patient can be difficult and time consuming withcommonly used metal jigs. Another embodiment of the present invention isdirected to devices and methods configured for facilitating theconstruction of anchor portions, such as the anchor portion 244 fromFIG. 18, having complex geometries. In one preferred embodiment, adisposable jig is provided on which an anchor portion may be shaped toconform to the anatomy of the target location. Initially, a master jigshape is created from which disposable jigs are later created. The shapeof the jigs provides the surfaces on which the shape memory material(e.g., Nitinol) is shaped. Preferably, this master jig can be designedwith 3D CAD software, and then created using 3D stereolithographyprinters, such as those from Z Corp. of Burlington, Mass. Alternately,the master jig can be created by hand.

With reference to FIGS. 19A and 19B, in one preferred embodiment, amaster jig 300 is created from a 3D CAD design and a 3D printer. Themaster jig 300 includes a plurality of channels 302 and 303 into whichshape-memory wire or retaining members can later be placed on thedisposable copy of the jig 300. Since the master jig 300 of the presentexample is created with a 3D printer which “prints” with a plastic, themaster jig 300 includes an expansion hole 304 to prevent the shape ofthe master jig 300 from distorting as it cools.

Next, a mold 306 is created from the master jig 300 from whichdisposable jigs are later created, as depicted in FIG. 20. The mold 306can be created by placing the master jig 300 into a container and filingthe container with liquid silicone. The silicone is allowed to solidifyand is then cut in half to remove the master jig 300. This leaves animpression of the master jig 300 in the silicone which becomes thedisposable jig mold 306.

Each disposable jig is formed from a liquid material that hardens withinthe mold 306. Since the shape memory materials that are later placed onthe disposable jigs are typically heat treated to retain their jigshape, the disposable jig material is preferably heat resistant also.One example of a disposable jig material is commonly known as dentalgypsum (e.g., semi-hydrate calcium sulphate) which is commonly used inthe dental community for making molds and impressions of teeth. Dentalgypsum is poured into each half of the mold 306 (which has beenpreviously split open to remove the master jig 300). The dental gypsumis typically mixed into a liquid/paste form and allowed to harden to theshape of the mold 306 (hardening typically takes about 3 hours). The endresult of filing the mold 306 is a solid jig, including the shape anddepressions of the original master jig 300.

With reference to FIG. 21, a disposable jig 310 is formed from thepreviously described mold 306. As shown in the illustrated embodiment,shape memory wires 314 are positioned within the longitudinal channels302 along the jig 310. Prior to heat treatment to change the relaxedshape of the shape-memory wire 314, the shape-memory wire 314 may notmaintain its position within the channels 302. Thus, retaining elementssuch as circular wires 316 and pins 318 may be used to hold theshape-memory wire 314 in place. In the present example, the circularwires 316 are placed within latitudinal channels 303, crossing over theshape-memory wires 314. Similarly, pins 318 are positioned at variouslocations near the wires 314 and 316 to maintain the wire's position onthe jig 310.

The disposable jig 310 may also include a mounting bracket 312 whichlocks onto the free ends of the shape-metal wires 316. The mountingbracket 312 also provides a mounting point by which the jig 310 can bemounted onto a vice or other tool.

When the shape-memory wires 316 have been secured on the jig 310 at adesired location, the jig 310 is placed into a heat source, such as anoven. This heat sets the shape of the shape-memory metal 314 as is wellknown in the art. After the heat, the user is free to remove theshape-memory wires 314 from the jig 310. Since the jig 310 is disposableand preferably made from dental gypsum, the user may wish to break thejig 310 with a hammer to quickly remove the newly formed anchoringregion 320, as seen in FIG. 22.

In one example of such a heating process, a 50 gram gypsum jig 310 withSuper Elastic Alloy N Nitinol wires 314 can be heated to about 570degrees Celsius for about 20 minutes. The jig 310 is then removed to aircool for less than a minute and then rapidly cooled in room temperaturewater. The wires 314 can be removed from the jig (e.g., the jig can bebroken), placed back into the heat source for about 10 minutes, thencooled in the same manner as previously described.

The invention has generally been described herein for use inminimally-invasive procedures conducted through one or more relativelysmall incisions in the chest cavity. However, the devices and methods ofthe invention could also be applicable in other procedures, such as ingeneral (e.g., open-chest) surgical procedures and percutaneousprocedures.

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. Accordingly, it is to be understood that the drawingsand descriptions herein are proffered by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof.

What is claimed is:
 1. A method of deploying a blood-flow controllingdevice for treating a mitral or tricuspid valve in need thereof, themethod comprising: providing a blood-flow controlling device having: ablood-flow blocking portion slidable over a flexible, elongate bodyportion, the blood-flow blocking portion comprising an elongatestructure with a substantially cylindrical portion, a portion of theblood-flow blocking portion configured to be disposed between leafletsof a native mitral or tricuspid valve and the blood-flow blockingportion being fillable with blood, and an anchor disposed on a distalend of the elongate body portion, the anchor engageable with hearttissue at or adjacent a heart apex, the anchor comprising a tubular bodyand a plurality of pointed, elongated prongs emanating from a distal endof the tubular body, the plurality of elongated prongs self-expandablefrom a compressed configuration, in which the plurality of elongatedprongs extend distally, and an expanded configuration, in which theplurality of elongated prongs are deflected radially outward relative toa center of the tubular body; providing an anchor delivery catheter fordelivering the anchor having a distal end sheath that maintains theplurality of elongated prongs in the compressed configuration; advancingthe anchor delivery catheter through the mitral or tricuspid valve andinto an adjacent ventricle; deploying the anchor in ventricular tissueby expelling the anchor from the distal end sheath; sliding theblood-flow blocking portion relative to the elongate body portion andpositioning the blood-flow blocking portion between the leaflets of themitral or tricuspid valve; providing a locking catheter slidable alongthe elongate body portion, locking the blood-flow blocking portion tothe elongate body portion with the locking catheter, preventing slidingtherebetween.
 2. The method of claim 1, wherein the blood-flow blockingportion further comprises a bendable lumen through which the elongatebody portion extends, the method including using the locking catheter todeform the bendable lumen and lock the blood-flow blocking portion tothe elongate body portion.
 3. The method of claim 2, wherein thebendable lumen is within a bendable tube extending from a proximal endof the blood-flow blocking portion, the bendable tube being plasticallydeformable to lock the blood-flow blocking portion to the elongate bodyportion.
 4. The method of claim 1, wherein the anchor delivery catheterincludes an expandable balloon positioned around a portion of the distalend sheath, the expandable balloon being expandable during the step ofadvancing the anchor delivery catheter so as to assist in advancementthereof by preventing entanglement of the anchor with chordae tendinaeand other sub-valvular structures.
 5. The method of claim 1, wherein theanchor further comprises a coupling member to which a connector at thedistal end of the elongate body portion is couplable.
 6. The method ofclaim 1, further including a leash extending from a proximal end of theblood-flow blocking portion, the method including anchoring the leash totissue in an atrium adjacent the mitral or tricuspid valve and restrainunwanted movement of the blood-flow blocking portion.
 7. The method ofclaim 1, wherein the blood-flow blocking portion is dimensioned forpositioning between leaflets of the native mitral valve.
 8. The methodof claim 1, wherein the blood-flow blocking portion is dimensioned forpositioning between leaflets of the native tricuspid valve.
 9. A methodof deploying a blood-flow controlling device for treating a mitral ortricuspid valve in need thereof, the method comprising: providing ablood-flow controlling device having: a blood-flow blocking portionslidable over a flexible, elongate body portion, the blood-flow blockingportion comprising an elongate structure, a portion of the blood-flowblocking portion disposable between leaflets of a native mitral ortricuspid valve and Tillable with blood, and an anchor disposed on adistal end of the elongate body portion, the anchor engageable withheart tissue at or adjacent a heart apex; providing an anchor deliverycatheter for delivering the anchor having a distal end sheath from whichthe anchor is expelled; advancing the anchor delivery catheter throughthe mitral or tricuspid valve and into an adjacent ventricle; deployingthe anchor in ventricular tissue; sliding the blood-flow blockingportion relative to the elongate body portion and positioning theblood-flow blocking portion between the leaflets of the mitral ortricuspid valve; providing a locking catheter slidable along theelongate body portion, locking the blood-flow blocking portion to theelongate body portion with the locking catheter, preventing slidingtherebetween.
 10. The method of claim 9, wherein the blood-flow blockingportion comprises a substantially cylindrical portion.
 11. The method ofclaim 9, wherein the anchor comprises an inner anchor plate and an outeranchor plate.
 12. The method of claim 9, wherein the anchor comprises atubular body and a plurality of pointed, elongated prongs emanating froma distal end of the tubular body, the plurality of elongated prongsself-expandable from a compressed configuration, in which the pluralityof elongated prongs extend distally, and an expanded configuration, inwhich the plurality of elongated prongs are deflected radially outwardrelative to a center of the tubular body.
 13. The method of claim 9,wherein the anchor further comprises a coupling member to which aconnector at the distal end of the elongate body portion is couplable.14. The method of claim 9, wherein the blood-flow blocking portionfurther comprises a bendable lumen through which the elongate bodyportion extends, the method including using the locking catheter todeform the bendable lumen and lock the blood-flow blocking portion tothe elongate body portion.
 15. The method of claim 14, wherein thebendable lumen is within a bendable tube extending from a proximal endof the blood-flow blocking portion, the bendable tube being plasticallydeformable to lock the blood-flow blocking portion to the elongate bodyportion.
 16. The method of claim 9, wherein the blood-flow blockingportion is dimensioned for positioning between leaflets of the nativemitral valve.
 17. The method of claim 9, wherein the blood-flow blockingportion is dimensioned for positioning between leaflets of the nativetricuspid valve.
 18. The method of claim 9, wherein the anchor comprisesa plurality of elongated prongs self-expandable from a compressedconfiguration, and the anchor delivery catheter distal end sheathmaintains the plurality of elongated prongs in the compressedconfiguration, and the step of deploying the anchor in ventriculartissue includes expelling the anchor from the distal end sheath.
 19. Themethod of claim 18, wherein the anchor delivery catheter includes anexpandable balloon positioned around a portion of the distal end sheath,the expandable balloon being expandable during the step of advancing theanchor delivery catheter so as to assist in advancement thereof bypreventing entanglement of the anchor with chordae tendinae and othersub-valvular structures.
 20. The method of claim 9, further including aleash extending from a proximal end of the blood-flow blocking portion,the method including anchoring the leash to tissue in an atrium adjacentthe mitral or tricuspid valve and restrain unwanted movement of theblood-flow blocking portion.